# K954572: Maestro Clinical Remote Control

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jun 26, 1996 after 268 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910194 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910194: Companion 318 Nasal Cpap Diagnostics System, Puritan Bennett Corp. (1991) Summary page 1.
- K920699: Remstar Wtih Ramp and Remote Modification, Respironics, Inc. (1992) Summary page 1.

## Indications for use
The Maestro CRC is an optional accessory that provides remote control capabilities when used in conjunction with Respironics Aria CPAP and Virtuoso Smart CPAP Systems and is intended for use by a qualified clinician (any individual trained to perform sleep study diagnoses) in hospital/sleep laboratory settings where adult patients suffering from OSA are diagnosed and treated.

Source page: https://510kreport.com/device/K954572
Methodology: https://510kreport.com/methodology